Johnson & Johnson has announced that the U.S. Food and Drug Administration has approved a new once-monthly dosing schedule for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in combination with LAZCLUZE (lazertinib) for the first-line treatment of Epidermal Growth Factor Receptor (EGFR)-mutated advanced Non-Small Cell Lung Cancer (NSCLC).

The newly approved monthly regimen demonstrated consistent efficacy and safety outcomes compared with the previously approved bi-weekly subcutaneous dosing schedule. Patients may transition to the once-monthly schedule as early as Week five of treatment.

The approval builds on the recent authorisation of RYBREVANT FASPRO, which significantly reduced administration time from hours to minutes and lowered administration-related reactions fivefold compared with intravenous delivery.

Clinical data from the PALOMA-2 study, recently presented at the World Conference on Lung Cancer, showed that monthly RYBREVANT FASPRO combined with LAZCLUZE achieved a high objective response rate in previously untreated EGFR-mutated advanced NSCLC patients. Rates of administration-related reactions were comparable to the bi-weekly subcutaneous schedule and substantially lower than historical intravenous data.

Safety findings for the monthly dosing schedule were consistent with prior intravenous and bi-weekly subcutaneous administration. Most adverse events were linked to EGFR/MET inhibition, with no new safety signals identified. Treatment discontinuation due to adverse events occurred in 8 percent of patients.

Company executives said the once-monthly injection offers greater convenience while maintaining strong clinical outcomes, potentially allowing patients to spend less time in clinics and more time focusing on quality of life.